APC: FDA extends comment period on 503B Bulks List

January 15, 2021

FDA extends comment period on 503B Bulks List

Last week, FDA announced that it was reopening the comment period for it’s proposed updated 503B Bulks List — the “bulk drug substances (active pharmaceutical ingredients) that FDA has considered and proposes to include or not include on the list of bulk drug substances for which there is a clinical need.”

Comments can now be submitted until February 8, 2021, and APC is considering commenting.

Simply put: We welcome member input about what should be the substance of those comments. Nothing formal (on your end); all you need to do is send an email to scott@a4pc.org.